Lead Quality & Regulatory Specialist

Broadgate; Greater London; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading innovative digital health company is seeking a Lead Quality & Regulatory Specialist in London. This role will support the VP of Regulatory in developing and executing regulatory strategies, ensuring compliance across US, UK, and EU. Candidates should have over 6 years of experience in Regulatory Affairs and Quality Assurance within medical devices or digital health, with strong knowledge of ISO standards and FDA submissions. Competitive compensation and benefits available.

Qualifications

• Minimum 6 years’ experience in Regulatory Affairs and Quality Assurance.
• Proven experience with Class II or higher FDA/EU MDR submissions.
• Strong understanding of regulatory frameworks and adherence to standards.

Responsibilities

• Support global regulatory and quality strategies.
• Prepare documentation for FDA and UK MHRA submissions.
• Assist in maintaining Quality Management System aligned with ISO 13485.

Skills

Regulatory Affairs expertise

Quality Assurance knowledge

Understanding of ISO 13485

Experience with FDA submissions

Experience with EU MDR submissions

Tools

MasterControl

Greenlight Guru

Job description

Lead Quality & Regulatory Specialist

Location : London

A leading innovative digital health company is seeking a Lead Quality & Regulatory Specialist to support the VP of Regulatory in developing and executing quality and regulatory strategies for Software as a Medical Device.

This hands‑on role will be instrumental in building and maintaining regulatory compliance frameworks across the US, UK, and EU, helping prepare products for certification and market clearance.

Role Responsibilities

• Support the development and execution of global regulatory and quality strategies.
• Prepare and review documentation for FDA, EU MDR, and UK MHRA submissions.
• Define device intended use, risk classification, and regulatory pathways for SaMD.
• Assist in the implementation and maintenance of the Quality Management System aligned with ISO 13485 , 21 CFR Part 820 , and EU MDR .
• Draft and maintain SOPs, work instructions, and templates.
• Contribute to the creation and management of technical documentation and medical device files.
• Support internal and external audit readiness, including training and CAPA management.
• Partner with cross‑functional teams to ensure regulatory requirements are integrated into product development.

Requirements

• 6+ years’ experience in Regulatory Affairs and Quality Assurance within medical devices, digital health, or SaMD.
• Proven experience with FDA and / or EU MDR submissions (Class II or higher).
• Strong understanding of regulatory frameworks and standards, including ISO 13485 , ISO 14971 , IEC 62304 , and 21 CFR Part 820 .
• Hands‑on experience supporting QMS implementation and audit preparation.

Desirable

Desirable: Experience setting up QMS from scratch, using regulatory tools (e.g., MasterControl, Greenlight Guru), or acting as PRRC / Deputy PRRC.